Surgical patch cover and method of use

ABSTRACT

A device for performing surgery on a patient includes: a mesh patch comprising a top surface and a bottom surface; and a removable cover positioned adjacent to and in facing engagement with the bottom surface of the mesh patch. The bottom surface has a plurality of hooks positioned thereon. The cover is removed from the mesh patch as the mesh patch is positioned at a surgical site such that the hooks on the bottom of the mesh patch grip surrounding tissue of a patient and secure the mesh patch to surrounding tissue of the surgical site. A method for performing a surgery using such a device is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.13/319,219 filed Mar. 28, 2012, which is a National Stage Application ofPCT/US10/33673 filed May 5, 2010, which claims benefit of and priorityto U.S. Provisional Application No. 61/176,157 filed May 7, 2009, andthe disclosures of each of the above-identified applications are herebyincorporated by reference in their entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention, in general, is directed to a mesh patch forsurgical procedures and, more particularly, to a cover for such meshpatches and methods of performing surgeries with such mesh patches.

2. Description of Related Art

The groin is one of the natural weak areas in the abdominal wall and isthe most common site for abdominal herniation. In particular, inguinalhernias are defined as those occurring above the abdominocrural crease.Inguinal hernias are usually classified as direct or indirect. The sacof an indirect inguinal hernia passes obliquely or indirectly toward andultimately into the scrotum. The sac of a direct inguinal herniaprotrudes directly outward and forward. Clinically distinguishing anindirect from a direct inguinal hernia is often impossible and is oflittle importance since the operation to repair them is substantiallythe same.

Traditionally, inguinal hernias have been repaired via one of two typesof operative procedure. A first technique is a laparoscopic approachwhich requires the patient to be under a general anesthetic. However,this approach is less preferred because it has a high early recurrencerate and a steep learning curve for the surgeon. A more preferredapproach is called an “open technique” in which a small two (2) to three(3) inch incision is made in the inguinal area after the patient isunder local, regional, or general anesthesia and the hernia is repaired.

In order to enhance the “open technique”, surgically implantable meshpatches for the repair of inguinal and other abdominal wall hernias havebeen provided. Tension free surgical repairs of hernias have beendeveloped using-synthetic mesh materials to bridge and to patch herniadefects. Repairs utilizing such surgically implantable mesh patchesresulted in both a decrease in the recurrence rate as well as a decreasein the amount of a patient's post operative discomfort. Patientsundergoing these more advanced procedures were able and are able toresume their normal activities sooner.

With reference to FIGS. 1 through 3, an example of such a mesh patch,denoted generally as reference numeral 1, is the Paritex ProGrip™. Meshmanufactured by Covidien AG, 150 Glover Avenue, Norwalk, Conn. 06856.Mesh patch 1 has, viewed from above, the general shape of an ellipse.This ellipse includes a lower edge 3 a and an upper edge 3 b with alarge radius of curvature and two lateral edges 3 c, 3 d with a smallradius of curvature. The shape of upper edge 3 b is specifically adaptedto the anterior inguinal region and more precisely to the space formedafter opening of the aponeurosis of the external oblique muscle, accessto the conjoined tendon and the aponeurosis of the rectus muscle, thelatter being fixed between the insertion of the aponeurosis of theexternal oblique muscle and that of the rectus muscle. This anatomicalasymmetry combined with the presence of a flap 5 means mesh patch 1 canprovide either a right reinforcement or a left reinforcement. Mesh patch1 shown in FIG. 1 is a right reinforcement (relative to the patient).The large curvature of lower edge 3 a allows a perfect match to thecrural arch as far as the pubis.

Mesh patch 1 also includes a slit 7 positioned perpendicular to upperedge 3 b and extending substantially over half of the width of meshpatch 1. The inner end of slit 7 opens into an orifice 9 which iscylindrical and which, for example, has a diameter of 3 to 7millimeters. Flap 5 has a shape of a sector of a circular annulus and isconnected via one of its radial edges to one of the edges of mesh patch1 which delimits the slit 7. Flap 5 is joined to mesh patch 1 in such away that the concavity of its inner and outer arched edges is directedtowards orifice 9.

Mesh patch 1 is made of a sheet of low-weight monofilament polyesterknitted fabric 11 having a top surface 13 and a bottom surface 15. Thepolyester knitted fabric 11 has a low weight isoelastic structure withlarge pores as shown in FIG. 2. In addition, polyester knitted fabric 11incorporates resorbable polylactic acid (PLA) micro-hooks 17 on bottomsurface 15 thereof. Resorbable PLA micro-hooks 17 provide self-grippingproperties to mesh patch 1 during a procedure and the first monthpost-implantation. Mesh patch 1 is configured to be secured around aspermatic cord of the patient using flap 5. Flap 5 is made of the samefabric as mesh patch 1 (i.e., polyester with polylactic acid micro-hooksknitted fabric), thereby providing it with self-gripping properties.After complete tissue ingrowth and complete resorption of PLAmicro-hooks 17, mesh patch 1 ensures long term abdominal wallreinforcement.

However, the implantation of such a patch can be challenging. Moreparticularly, during implantation using the recommended procedure, PLAmicro-hooks 17 of mesh patch 1 can stick to tissue surrounding theimplantation site and may need to be removed from such tissue. As meshpatch 1 is removed, the fragile PLA micro-hooks can be torn from bottomsurface 15 of mesh patch 1. Accordingly, once mesh patch 1 arrives atthe desired location, most, if not all, of the PLA micro-hooks 17 may bedisengaged from bottom surface 15 of mesh patch 1, and the surgeon maybe required to stitch mesh patch 1 in position. In addition, if flap 5is positioned too loose or tight around the patient's spermatic cordvarious problems can arise. For instance, positioning flap 5 too tightlyaround the spermatic cord can lead to testicular ischemia whereaspositioning flap 5 too loosely around the spermatic cord can lead to arecurrent hernia.

Accordingly, a need exists for a removable cover for mesh patch 1 thatprevents PLA micro-hooks 17 from securing themselves to surroundingtissue during implantation of mesh patch 1. In addition, a need existsfor a surgical method of implanting mesh patch 1 using such a cover.

SUMMARY OF THE INVENTION

In some embodiments the present invention provides a surgicalcombination having a removable cover for a mesh patch that prevents themicro-hooks of the mesh patch from securing themselves to surroundingtissue during implantation of the patch. Another aspect of the presentinvention is to provide a surgical method of implanting a mesh patchusing such a cover.

The present invention provides a device for performing surgery on apatient. The device comprises: a mesh patch comprising a top surface anda bottom surface; and a removable cover positioned adjacent to and infacing engagement with the bottom surface of the mesh patch. The bottomsurface has a plurality of hooks positioned thereon. The cover isremoved from the mesh patch as the mesh patch is positioned at asurgical site such that the hooks on the bottom of the mesh patch gripsurrounding tissue of a patient and secure the mesh patch to surroundingtissue of the surgical site.

The present invention also provides a surgical combination thatcomprises a mesh patch having a top surface and a bottom surface; and aremovable cover positioned adjacent to and in facing engagement with thebottom surface of the mesh patch. The bottom surface has a plurality ofhooks positioned thereon. The cover is removed from the mesh patch asthe mesh patch is positioned at a surgical site such that the hooks onthe bottom of the mesh patch grip surrounding tissue of a patient andsecure the mesh patch to surrounding tissue of the surgical site.

The present invention is further directed to a kit for surgical repair.The kit comprises a mesh patch comprising a top surface and a bottomsurface; and a removable cover configured to be positioned adjacent toand in facing engagement with the bottom surface of the mesh patch. Thebottom surface has a plurality of hooks positioned thereon. The cover isremoved from the mesh patch as the mesh patch is positioned at asurgical site such that the hooks on the bottom of the mesh patch gripsurrounding tissue of a patient and secure the mesh patch to surroundingtissue of the surgical site. The kit may further comprise an additionalsheet of polymeric material configured to be cut into pieces by asurgeon to line the surgical site prior to positioning the cover andpatch.

The present invention also provides a method for repairing an abdominalwall hernia. The method includes the steps of: a) cutting a transverseoblique incision in a fold of a groin of a patient; b) widely dissectinga superficial inguinal space of the patient, thereby freeing fascialsurfaces and creating a surgical site; c) mobilizing a spermatic cord ofthe patient using a latex band; d) repairing the abdominal wall herniaand making a relaxing incision in an internal oblique fascia of thepatient; e) providing a device that includes a mesh patch with a topsurface and a bottom surface having a plurality of hooks positionedthereon; and a removable cover having a first side positioned on thebottom surface of the mesh patch; f) positioning the device over thesurgical site such that a second side of the cover is adjacent to thesurgical site; g) removing the cover as the mesh patch is positioned atthe surgical site such that the hooks on the bottom of the mesh patchgrip the surrounding tissue and secure the mesh patch to the surgicalsite; and h) closing the incision with stitches. The method may furthercomprise the step of lining the surgical site with pieces of a sheet ofpolymeric material prior to step e).

These and other features and characteristics of the present invention,as well as the methods of operation and functions of the relatedelements of structures and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. As used in the specification and the claims, thesingular form of “a”, “an”, and “the” include plural referents unlessthe context clearly dictates otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a conventional mesh patch for use inrepairing abdominal wall hernias;

FIG. 2 is a magnified photographic view of the bottom surface of themesh patch of FIG. 1;

FIG. 3 is a cross-sectional view of the mesh patch of FIG. 1 taken alongline 3-3;

FIG. 4 is a perspective view of a device for performing surgery on apatient in accordance with the present invention;

FIG. 5 is a top plan view of a kit for use in performing a surgicalrepair in accordance with the present invention;

FIG. 6 is a schematic front view of a patient's body indicating, inrespect to the surgical repair of an inguinal hernia, where an incisionis made in a fold of a groin of the patient; and

FIGS. 7 through 14 illustrate the various steps of a method forrepairing an inguinal hernia using the device of the present invention.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

With reference to FIG. 4, a device, denoted generally as referencenumeral 19, for performing surgery comprises a mesh patch 1 as describedhereinabove; and a removable cover, denoted generally as referencenumeral 21.

While the mesh patch configuration is discussed with respect to a patchfor hernia repair, one skilled in the art will understand that the shapeof the patch can vary, depending upon the surgical procedure to beperformed, and may or may not include a flap. The mesh patch 1 comprisesa top surface 13 and a bottom surface 15 opposite the top surface 13. Insome non-limiting embodiments, mesh patch 1 can have a generallyellipse-like shape that includes a lower edge 3 a and an upper edge 3 bwith a large radius of curvature and two lateral edges 3 c, 3 d with asmall radius of curvature. A slit 7 is positioned perpendicular to upperedge 3 b and extending substantially over half of the width of meshpatch 1. The inner end of slit 7 opens into an orifice 9. A flap 5having a shape of a sector of a circular annulus is also provided and isconnected via one of its radial edges to one of the edges of mesh patch1 which delimits the slit 7.

Mesh patch 1 can be made of a sheet of low-weight monofilament polyesterknitted fabric 11 having a top surface 13 and a bottom surface 15.However, this is not to be construed as limiting the present inventionas any suitable material, for example, a plastic material such aspolypropylene, may be used. Mesh patch 1 also comprises a plurality ofhooks 17. In addition, polyester knitted fabric 11 incorporatesbioresorbable polylactic acid (PLA) micro-hooks 17 on bottom surface 15thereof

Removable cover 21 has a top side 23 and a bottom side 25. Top side 23of cover 21 is configured to be positioned adjacent to and in facingengagement with bottom surface 15 of mesh patch 1. Bottom side 25 isconfigured to be positioned adjacent to a surgical site as will bediscussed in greater detail hereinafter. Removable cover 21 may be ofany suitable size such that it completely covers bottom surface 15 ofmesh patch 1. For example, if mesh patch 1 has an elliptical shape thatis 12 cm by 8 cm, the removable cover 21 may be of a rectangular orelliptical shape that is 15 cm by 9 cm. In addition, removable cover 21may have a thickness in the range of 0.005 mm to 1 mm.

Removable cover 21 is provided as a layer of sterile, smooth polymericmaterial such as a polymer film manufactured from polyolefins, such aspolypropylene. Desirably, removable cover 21 is prepared from the samematerial as the inner, sterile liner of esteem SMT non-porous,powder-free, latex-free surgical gloves distributed by Cardinal Health,McGaw Park, Ill. 60085. As shown in FIG. 4, device 19 may bemanufactured and sold as a combination. Alternatively, mesh patch 1 andremovable cover 21 may be sold as individual components and used incombination.

In addition, and as shown in FIG. 5, mesh patch 1 and removable cover 21may be sold in a kit, denoted generally as reference numeral 27. Kit 27includes mesh patch 1 and removable cover 21 provided in a package 29.Package 29 may also include one or more additional sheet(s) 31 ofsterile, polymeric material configured to be cut into pieces by asurgeon to line the surgical site prior to positioning the combinationof removable cover 21 and mesh patch 1. Sheet 31 can be prepared fromany sterile surgical polymer material, and can be prepared from the samepolymeric material as removable cover 21, if desired. While an exemplaryembodiment of kit 27 is illustrated in FIG. 5, this is not to beconstrued as limiting the present invention as any number ofconfigurations for kit 27 has been envisioned.

With reference to FIGS. 6-14, and with continuing reference to FIGS. 4and 5, the method for repairing an inguinal hernia using device 19and/or kit 27 of the present invention is described hereinafter. Whilethe following description is provided for the repair of an inguinalhernia, the device of the present invention is not limited to use inrepairing inguinal hernias. Different shapes and sizes of mesh patch 1and removable cover 21 may be provided to perform various types ofsurgery where mesh patches are used, such as laparoscopic ventral herniarepair, diaphragmatic hernia repair, and soft tissue reconstruction.

The repair of an inguinal hernia in accordance with the procedure of thepresent invention begins with the cutting of a transverse obliqueincision 33 in a fold of a groin of a patient 35. Thereafter, asuperficial inguinal space of patient 35 is widely dissected, therebyfreeing fascial surfaces 37 and creating a surgical site 39 (see FIG.7). Next, the spermatic cord 41 of patient 35 is mobilized using a latexband 43 (see FIG. 8). In some instances, latex band 43 may be coveredwith a piece of polymeric material cut from additional sheet 31.

The surgeon then identifies a hernia sac (indirect hernia) or a herniabulge (direct hernia), and repairs the hernia. Thereafter, a relaxingincision 51 in the internal oblique fascia is made by the surgeon toreduce tension in this area. For an indirect hernia, the surgeontightens the internal inguinal ring with an absorbable stitch. For adirect hernia, the hernia sac 45 is imbricated to temporarily reduce thehernia bulge and then the superior and medial portion of the transverselayer is drawn downward and sutured to the superior pubic ligament asdenoted by reference numeral 47 and to the anterior femoral sheath asdenoted by reference numeral 49 (see FIG. 9).

As shown in FIG. 10, the surgeon then increases the size of surgicalsite 39 using a flag retractor 53 and a Gelpi retractor 55. In addition,at this point in the surgical procedure, the surgeon also may linesurgical site 39 with pieces cut from additional sheet 31 of polymericmaterial. Then, device 19 of the present invention is positioned oversurgical site 39 such that bottom side 25 of removable cover 21 isadjacent to surgical site 39 (see FIGS. 11 and 12). As discussedhereinabove, device 19 may be provided as a prepackaged unit, as a kit,or as separate cover 21 and mesh patch 1 components.

Removable cover 21 covers micro-hooks 17 until the surgeon maneuversmesh patch 1 into a proper position, thereby avoiding accidentalexposure of micro-hooks 17 to prevent premature fixation to structuresthat destroy the fragile nature of micro-hooks 17. A slit 56 may be cutinto cover 21 to correspond with slit 7 provided in mesh patch 1. Flap 5is folded on itself and held temporarily open with an Alice clamp 57.Alice clamp 57 looks like a hemostat but has “c”-shaped tips that onlycontact a very small surface area so as to not crush too manymicro-hooks 17.

Next, the surgeon directs mesh patch 1 medially over the pubic tubercle59 such that slit 7 of mesh patch 1 is toward the patient's head andflap 5 is open. Once mesh patch 1 is in position, removable cover 21 isslid laterally in the direction of arrow A to expose bottom surface 15and micro-hooks 17 of mesh patch 1 to surgical site 39 (see FIG. 13).The surgeon then gently presses mesh patch 1 into pubic tubercle 59overlapping the inguinal ligament, and extends mesh patch 1 to coverrelaxing incision 51. Desirably, an assistant exerts an upward pressureon the surrounding tissue with a Richardson (blunt) retractor (notshown). Thereafter, the surgeon continues to slide cover 21 laterallyalong the inguinal ligament in the direction of arrow A while moving theretractor to the lateral border of incision 33. Once edges 3 a and 3 dof mesh patch 1 have been fixed, the remainder of mesh patch 1 isproperly positioned around spermatic cord 41. In some instances, thesurgeon may need to place stitches along the border of the inguinalligament to assure mesh patch 1 does not move.

The final step in positioning mesh patch 1 is to remove Alice clamp 57and to close flap 5 around spermatic cord 41, thus creating a newinternal ring that is completely tension free and custom made (see FIG.14). Once mesh patch 1 is in place, all pieces of additional sheet 31that may have been placed in incision 33 are removed along with anylatex bands (around the spermatic cord). The external fascial surfaces37 are then closed with an absorbable stitch, and the skin is alsoclosed with an absorbable stitch.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical embodiments, it is to be understood that such detail is solelyfor that purpose and that the invention is not limited to the disclosedembodiments, but, on the contrary, is intended to cover modificationsand equivalent arrangements. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

What is claimed is:
 1. A device for performing surgery on a patient, thedevice comprising: a mesh patch comprising a top surface and a bottomsurface, the bottom surface having a plurality of hooks positionedthereon; and a removable cover comprising a top side and a bottom side,the top side configured to be positioned adjacent to and in facingengagement with the bottom surface of the mesh patch and the bottom sideconfigured to be positioned adjacent to a surgical site, the removablecover further comprising a non-porous polymeric material, wherein thetop surface of the mesh patch is uncovered and the removable cover isconfigured to be removed from the bottom surface of the mesh patch asthe mesh patch is positioned at a surgical site such that the hooks onthe bottom surface of the mesh patch grip surrounding tissue of apatient and secure the mesh patch to surrounding tissue of the surgicalsite.
 2. The device of claim 1, wherein the mesh patch comprisespolyester, polypropylene, polylactic acid, or any combination thereof.3. The device of claim 1, wherein the hooks comprise a bioresorbablematerial.
 4. The device of claim 3, wherein the hooks comprisepolylactic acid.
 5. The device of claim 1, wherein the polymericmaterial comprises a polymeric film.
 6. The device of claim 5, whereinthe polymeric film comprises a single layer of non-porous polymericmaterial.
 7. The device of claim 1, wherein the surgical site is aportion of an abdominal wall in a groin area of a patient.
 8. A kit forsurgical repair comprising: a mesh patch comprising a top surface and abottom surface, the bottom surface having a plurality of hookspositioned thereon; and a removable cover a top side and a bottom side,the top side configured to be positioned adjacent to and in facingengagement with the bottom surface of the mesh patch and the bottom sideconfigured to be positioned adjacent to a surgical site, the removablecover further comprising a non-porous polymeric material, wherein thetop surface of the mesh patch is uncovered and the removable cover isconfigured to be removed from the bottom surface of the mesh patch asthe mesh patch is positioned at a surgical site such that the hooks onthe bottom surface of the mesh patch grip surrounding tissue of apatient and secure the mesh patch to surrounding tissue of the surgicalsite.
 9. The kit of claim 8, further comprising an additional sheet ofpolymeric material.
 10. The kit of claim 9, wherein the additional sheetis configured to be cut into pieces by a surgeon to line the surgicalsite prior to removing the cover from the mesh patch.
 11. The kit ofclaim 8, wherein the mesh patch comprises polyester, polypropylene,polylactic acid or any combination thereof.
 12. The kit of claim 8,wherein the hooks comprise a bioresorbable material.
 13. The kit ofclaim 12, wherein the hooks comprise polylactic acid.
 14. The kit ofclaim 8, wherein the removable polymeric material comprises a polymericfilm.
 15. The kit of claim 14, wherein the polymeric film comprises asingle layer of non-porous polymeric material.
 16. A method forrepairing an abdominal wall hernia comprising the steps of: a) forming asurgical incision in a groin area of a patient; b) dissecting asuperficial inguinal space of the patient, thereby freeing fascialsurfaces and creating a surgical site; c) repairing the abdominal wallhernia d) positioning a device over the surgical site, the devicecomprising a mesh patch comprising a top surface and a bottom surface,the bottom surface having a plurality of hooks positioned thereon; and aone-piece removable cover including a non-porous polymeric film layer,the removable cover having a top side positioned on the bottom surfaceof the mesh patch and a bottom side positioned adjacent the surgicalsite; e) sliding the one-piece removable cover laterally across thesurgical site and the bottom surface of the mesh patch exposing thehooks on the bottom surface of the mesh patch to grip surrounding tissueto secure the bottom surface of the mesh patch to the surgical site; andf) closing the surgical incision.
 17. The method of claim 16, furthercomprising the step of lining the surgical site with pieces of anadditional sheet of polymeric material prior to step d).
 18. The methodof claim 16, further comprises the step of mobilizing a spermatic cordof the patient using a latex band prior to repairing the abdominal wallhernia of step c).
 19. The method of claim 16, wherein the polymericfilm layer comprises a single layer.
 20. A surgical combinationcomprising: a mesh patch comprising a top surface and a bottom surface,the bottom surface having a plurality of absorbable hooks positionedthereon; and a one-piece removable cover comprising a single non-porouspolymeric film layer positioned adjacent to and in facing engagementwith the bottom surface of the mesh patch, wherein the one-pieceremovable cover is configured to protect the absorbable hooks prior toimplantation and slide laterally across the absorbable hooks to exposethe absorbable hooks upon implantation to grip to surrounding tissue ofa surgical site.